Baby food products containing allergenic proteins and methods of delivering same

ABSTRACT

Baby food products containing allergenic protein and methods of delivering the products are provided as a source of early introduction for prevention of food allergy in children. The product may be a solid or semi-solid product and includes an allergenic protein, one or more of a prebiotic or a probiotic, and a foodstuff. A method of feeding a baby food product to a child involves providing the child with a serving of the baby food product such that the child ingests a pre-defined amount of an allergenic protein. The serving may be provided on a periodic basis such that the child ingests a constant amount of the allergenic protein per week over an extended period.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/656,260, filed Jul. 21, 2017, which claims priority under 35 U.S.C. §120 to provisional application No. 62/365,609, filed on Jul. 22, 2016,entitled “BABY FOOD PRODUCTS CONTAINING ALLERGENIC PROTEINS AND METHODSOF DELIVERING SAME,” each of which is hereby incorporated by referenceherein in the entirety and for all purposes.

TECHNICAL FIELD

Baby food products containing allergenic proteins as a means of earlyintroduction, and methods of delivering these products, are provided forpreventing the development of food allergy in children.

BACKGROUND

Six million children in the world, or 8 percent of children, have foodallergies with young children being affected the most. Currently thestandard of care for food allergy is food avoidance, causing manyindividuals with food allergies to face lifelong avoidance of certainfoods.

1-2 percent of young children in developed countries have a peanutallergy, the prevalence of peanut allergy doubled from 1997 to 2002.Compared to non-nut or seed allergies, peanut allergies are more likelyto be a lifelong allergy and result in more severe reactions.Importantly, symptoms can occur following exposure to only very tiny (or‘trace’) amounts of peanut protein. Because peanuts are used in a widevariety of food products, trace amounts of peanut protein can be foundin many foods, from chocolate bars to fruit snacks, making avoidancedifficult.

Recommendations for the appropriate timing of introduction ofhighly-allergic foods into the diet have been debated given the lack ofhigh quality studies till recently. In 2000, the American Academy ofPediatrics recommended the introduction of certain highly allergenicfoods be delayed further in high-risk children: peanuts until age threeyears. Subsequently, this recommendation was altered to suggest thatintroduction of highly allergic foods did not need to be extended past4-6 months of age. Expert opinion now recommends active earlyintroduction of peanut into the diet at 4-6 months in infants at highrisk of peanut allergy, around 6 months in infants at moderate risk, anddoes not recommend avoidance of early introduction in the generalpopulation beyond 4-6 months.

Current standard of care of food allergy involves avoidance of foods,which can be difficult, particularly when a person consumes pre-packagedfoods or meals prepared outside of the home. When avoidance fails andthe child is exposed to food allergens, this can often result inallergic reactions with varying degrees of severity. Other treatmentsinvolve a controlled, increased exposure of allergens to the affectedperson over the course of treatment. During the treatment regimen,increasing levels of the allergen are administered. This step-wiseapproach to exposing the allergen to the affected person at increasinglevels over time helps increase the individual's tolerance to theallergen, meaning subsequent environmental exposure to the allergen maynot illicit an allergic response, or may reduce the severity of theallergic response. Once the regular exposure to the allergen stops,however, the individual's tolerance to the allergen may decrease, andthe individual may experience the same allergic reactions that wereexperienced prior to treatment.

SUMMARY

In view of the foregoing, there is a need to provide baby food productsand appropriate delivery approaches that introduce certain allergenicproteins into an infant's diet. The present disclosure addresses thisneed by providing solid and semi-solid baby food compositions containinga defined amount of allergenic protein and methods of delivering thesecompositions to babies and young children. The methods may providechildren with an early intervention to reduce the development of foodallergies by delivering allergenic proteins within a solid or semi-solidfoodstuff containing a defined amount with characterization of theprotein components (e.g., Ara h components in peanut protein),optionally along with a prebiotic and/or a probiotic.

Baby food products include an allergenic protein, optionally one or moreof a prebiotic or a probiotic, and a solid or semi-solid foodstuff.According to some embodiments, the allergenic protein is from one ormore of a peanut, tree nut or egg. The allergenic protein may be anon-animal based protein, such as a nut-based or a plant-based protein.The allergenic protein may be defatted, may be heat treated, or non-heattreated. The optional prebiotic may include, but is not limited to,galactooligosaccharides, fructooligosaccharides, oligosaccharidesinulin, or a combination. The optional probiotic may include, but is notlimited to, lactobacilli, saccharomyces, bifidobacteria strains,bacillus coagulans, or a combination. The foodstuff may be any solid orsemi-solid consumable food product such as a fruit or vegetable puree, agrain meal or mash or a cereal.

In some embodiments, the allergenic protein, prebiotic and/or probioticand foodstuff may be provided as a product admixture. In alternativeembodiments, the allergenic protein may be separate from some or allother product components and may be admixed just prior to use. In suchapproaches, the prebiotics and/or probiotics may be present in the babyfood components, or may separate from the foodstuffs and be admixed withthe allergenic protein, or may be separate from the baby food componentsand the allergenic protein and admixed just prior to use.

The product may be packaged in suitable packaging such as a flexiblepacket sealed by a cap, a sealed sachet, or a cup sealed by a lid orfoil with powdered product separate from the solid or semi-solidcomponent within the cup or on top.

The baby food product may contain a pre-defined amount of allergenicprotein per serving. For instance, each three to four ounce serving ofthe baby food product may contain two grams of allergenic protein.

Methods of feeding the baby food product to children may involveproviding a child with a serving of the baby food product such that thechild ingests a pre-defined amount of the allergenic protein. Theserving may be provided on a periodic basis such that the child ingestsa constant amount of the allergenic protein per week over an extendedperiod of time, e.g., weeks, months or years. The periodic basis may beevery day, once every two days, once every three days or combinations.Over an extended period of time, the amount of allergenic proteiningested by the baby may remain constant, such as at about 6 grams perweek.

DETAILED DESCRIPTION

The terms “infant”, “baby” and “child” are used interchangeably hereinand unless otherwise specified, relates to human infants from about 3months to toddlers of about 36 months of age.

A baby that is non-allergic to foods is one that has not been diagnosedwith a food allergy, or is one that has been exposed to a particularfood or foods and has not experienced an allergic reaction from theexposure.

In contrast to approaches for the treatment of food allergies inchildren, implementations of the present disclosure provide baby foodproducts and delivery approaches that may effectively reduce theprevalence of food allergy in children and are not intended to treat anexisting food allergy. The products of the present disclosure containallergenic proteins, which may be used in connection with methods ofrepeatedly exposing a child to the allergenic protein at an early agewhich can lead to immune tolerance of the protein. Evidence for thistheory comes from studying peanut exposure in several other countrieswhere children typically consume relatively high levels of peanutprotein from infancy onwards, yet fail to show the high rates of peanutallergy observed in Western countries where peanut is generally avoidedin early life. Furthermore, in a clinical trial on early peanutintroduction, regular peanut consumption begun in early infancy (4-11months) and continued until age 5 reduced the rate of peanut allergy inhigh risk infants by 80% compared to non-peanut-consumers (Du Toit etal., Randomized trial of peanut consumption in infants at risk forpeanut allergy, N. Engl. J. Med. 2015 Feb. 26; 372 (9):803-13). Expertopinion now recommends introducing peanut-containing products into thediet of high risk infants between 4-6 months of age and consideration ofintroduction around 6 months in those at moderate-risk in countrieswhere peanut allergy is prevalent, since delaying introduction to peanutallergy may be associated with an increased risk of developing peanutallergy (Togias A., et al., Addendum guidelines for the prevention ofpeanut allergy in the United States: Report of the National Institute ofAllergy and Infectious Diseases—sponsored expert panel, JACI. January2017; 139 (1):29-44). Additionally, experts recommend againstintentional avoidance of peanut beyond 4-6 months of age in the generalpopulation. In another clinical trial studying early introduction ofmultiple allergenic foods in “normal risk” population, infants whofollowed the protocol recommendations of regular allergenic foodconsumption starting at 3 months of age had a lower prevalence of peanutand egg allergy by 3 years of age (Perkin M. R., et al., RandomizedTrial of Introduction of Allergenic Food in Breast-fed Infants, N. Engl.J. Med., 2016 May 5; 374 (18):1733-43).

Baby Food Products

Baby food products of the present disclosure may include one or moreallergenic proteins, another solid or semi-solid foodstuff andoptionally a prebiotic and/or a probiotic. Some food products may bethose that can be consumed by a child either without the need to chew ormasticate the food prior to swallowing, or with little effort in chewingor masticating prior to swallowing. For instance, the product may be asemi-solid food such as a food puree or a mash or meal which may beswallowed without chewing or masticating. Other food products may bethose that are solid but also safe for child consumptions such ascereal, e.g., puffed cereal, which may dissociate rapidly once the foodenters the mouth and may require little or no chewing or masticatingprior to swallowing.

The allergenic proteins in the products of the present disclosure areproteins isolated from a food source, such as allergenic proteinisolates. For instance, the allergenic protein may be a food flour thathas been defatted to reduce the fat content of the protein source. Forinstance, fully or partially defatted peanut flour contains about 40 toabout 50 wt % protein, about 26 to about 35 wt % carbohydrates and about0 to about 28 wt % fat. Food flour may be provided based on proteincontent. For example, with a partially defatted peanut flour which is 14wt % fat and about 45 to about 50 wt % protein, then about 4 grams ofpeanut flour may be included to reach a protein content of about 2grams.

Allergenic proteins are generally derived from foods known to beallergenic including peanuts, tree nuts and hen's eggs. The allergenicprotein may be a non-animal based protein. Levels of protein componentsmay be specified for the product. Specific proteins present in theallergenic protein may include, but are not limited to: the peanutprotein components of Ara h 1, 2, 3, 6, and 9; the hen's egg proteincomponents of Gal d 1-4; the walnut protein components of Jug r1, Jugr3; the pistachio protein components of Pis v 1-4; the cashew proteincomponent of Ana O3; the hazelnut protein components of Cor a 9, 14, 1,and 8; the pecan protein component of Car i 1; the almond proteincomponents of Pru du 2S, conglutin, LPT, amandin, 4 and 5; and theBrazil nut protein components of Ber e1 and e2. One or more forms ofallergenic protein may be present in the product.

Allergenic protein may be present in raw form for nuts. For instance,peanut protein and/or tree nut protein may be in a raw, non-heat treatedform. Alternatively, the allergenic protein may be processed, forinstance by heat treatment. In some approaches, the product may containboth raw and processed allergenic protein from the same or differentprotein source.

Processing the allergenic protein through heat treatment may involveroasting, subjecting the protein to a Maillard reaction, or through hotfill processing. Roasting may involve roasting the food source orroasting the allergenic protein itself. The food source or theallergenic protein may be dry roasted, which involves applying heat inthe absence of oil or water to modify the protein. In addition oralternatively, the food source or the allergenic protein may beprocessed in the presence of reducing sugars to promote a Maillardreaction in which the reducing sugars react with amino acids in theprotein to produce a browned product. The Maillard reaction is a complexchemical reaction between an amino acid and a reducing sugar, such asglucose and galactose produced from hydrolysis. The reaction is commonlyin the presence of heat, which may be accelerated in an alkalineenvironment. The Maillard reaction results in non-enzymatic browning ofthe product. Additional protein sources such as whey may be present topromote such a reaction. Heat treatment of peanut protein or peanuts mayincrease the allergenicity of the peanut protein due to changes in theprotein epitopes. Such treatment of tree nuts may also alter the proteinepitopes to alter the protein's allergenicity. Heat treatment of eggprotein may decrease the allergenicity of the protein.

The disclosed products may be free of other portions of the foods, orderivatives of the foods, from which the allergenic protein is derived.For instance, in a baby food product containing allergenic peanutprotein in the form of peanut flour, the product may be free of otherpeanut components such as peanut oil, whole peanuts, or peanut butter.Products containing egg protein may be free of other egg components suchas egg yolk.

The allergenic protein may be protected or partially-protected with acoating. This may provide the protein with protection from degradationby other components of the baby food product. The coating may containthe prebiotic and/or the probiotic. For instance, the coating may be ayogurt-based coating.

A prebiotic and/or a probiotic may be included in the product and mayserve to promote protective immune responses in the presence ofallergenic food proteins. Prebiotics in the product may include, but arenot limited to, galactooligosaccharides, fructooligosaccharides,oligosaccharides inulin, or a combination. Vegetables such as asparagus,onions, leeks, garlic, artichoke and chicory, may provide a prebioticsource. Banana may provide a prebiotic source. Grains such as wheat branand wheat flour may additionally provide a prebiotic source. Probioticsinclude, but are not limited to, lactobacilli, saccharomyces, orbifidobacteria strains, bacillus coagulans, or a combination. Dairyproducts such as yogurt or cheese may provide sources of probiotics.

The standard recommended serving dose for a particularprebiotic/probiotic may be included in the product.

The products generally contain at least one additional foodstuff havingadditional nutrients such as other proteins, fats, carbohydrates, andfiber. The foodstuff may be a food puree, a mash or a meal. Forinstance, the food puree may be a fruit puree (e.g., apple, banana,pear, strawberry, cherry, or combinations) or a vegetable puree (e.g.,sweet potato, squash, carrot, potato, pea, cauliflower, broccoli,tomato, asparagus, onions, leeks, garlic, artichoke, chicory, orcombinations). Some vegetable purees, such as asparagus, onions, leeks,garlic, artichoke and chicory, may provide a prebiotic source. The mashor meal may be wet cereals. The mash or meal may include, but is notlimited to, grains, cereal grains, white rice, brown rice, wheat, wheatgerm, rye, barley, oats (e.g., oat flour or milled oats), or quinoa.Wheat bran and wheat flour in the baby food product may additionallyprovide a prebiotic source. In addition or alternatively, the foodstuffmay be a manufactured food such as a manufactured dry cereal, includinggrain-based puff cereals (e.g., rice cereal, corn cereal, or wheatcereal). In some implementations the foodstuff may be a dairy productsuch as yogurt or cheese which may provide sources of probiotics.

The baby food products of the present disclosure contain low levels offat. The fat content may be about 0 wt %, up to 1 wt %, up to 2 wt %, upto 3 wt % up to 4 wt %, up to 5 wt %, up to 10 wt %, up to 20 wt %, upto 25 wt %, about 1 to about 2 wt %, about 1 to about 3 wt %, about 1 toabout 4 wt %, about 1 to about 5 wt %, about 2 to about 5 wt %, about 3to about 5 wt %, about 1 to about 10 wt %, about 1 to about 20 wt %,about 1 to about 25 wt %, about 5 to about 10 wt %, about 5 to about 15wt %, about 5 to about 20 wt %, about 5 to about 25 wt %, about 10 toabout 15 wt %, about 10 to about 20 wt %, about 10 to about 25 wt %,about 15 to about 20 wt %, about 15 to about 25 wt %, or about 20 toabout 25 wt % of the product. This is in contrast to peanut-based foodproducts manufactured from peanut butter and puffed maize that containfat at about 35 wt % and peanut butter which contains fat at about 50 wt%.

The allergenic protein may account for about 1 to about 11 wt %, about 1to about 5 wt %, about 2 to about 5 wt %, about 3 to about 5 wt %, about3 to about 7 wt %, about 3 to about 11 wt %, about 1 to about 3.5 wt %,about 1.7 to about 3.5 wt %, or about 3.5 wt % of the baby food product.In one example, the allergenic protein may be present at about 0.5 toabout 1 gram(s) per ounce (28.35 g) of the baby food product. Additionalprotein sources may raise the protein level of the baby food to higherlevels, such as about 4 wt %, about 5 wt %, about 6 wt %, about 7 wt %,about 8 wt %, about 9 wt %, about 10 wt %, about 15 wt %, about 20 wt %.Other protein sources include, but are not limited to, dairy protein(e.g., milk protein), hen's egg, and plant proteins (e.g., soy). In someimplementations, the allergenic protein may account for about 3 to about10 wt % of the baby food, while other protein sources may account forthe balance of the protein up to about 20 wt %. For instance, theproduct may be a yogurt that contains up to 10 wt % milk protein and oneor more allergenic proteins ranging from about 3 to about 10 wt % of theproduct. The allergenic protein may serve as a partial or full proteinreplacement for protein sources in the products. Where multipleallergenic proteins are present, each allergenic protein may be presentat the aforementioned levels, or the total allergenic protein present atthe aforementioned levels. For instance, multiple allergenic proteinsmay account for about 1.7 to about 3.5 wt % of the baby food, or thetotal allergenic protein present may account for about 1.7 to about 3.5wt % of the baby food.

Other components that may be present in the product include, but are notlimited to natural preservatives, viscosifiers, stabilizers, thickeners,emulsifiers, suspension agents (e.g., gums), micronutrients,macronutrients, vitamins and minerals. The pH of the product may beabout 3 to about 8.

In some implementations, the product may be free of any of theaforementioned foods. For instance, some children may have allergies towheat or wheat products such as wheat germ, and the product may be freeof these components.

The product may be packaged in suitable packaging such as a flexiblepacket sealed by a cap (e.g., a spouted squeeze pack), sealed sachet, orin a cup sealed by a lid or foil with powdered product separate fromsemi-solid component within the cup or on top. The packaging may containthe admixed product, or may contain components of the product inseparate compartments for admixing prior to use. For instance, theallergenic protein may be contained in a separate container within thesame single-serve package to be mixed into the other product components.In one example, the allergenic protein may be a dry composition includedin the single-serve pack, such as a paper sachet, which may be admixedwith the included solid or semi-solid food to be served.

In some examples, the packaged baby food product may contain about 0.5to about 1 gram of the allergenic protein per ounce of baby food. On aper serving basis, the product may contain about 1 to about 2 grams ofthe allergenic protein per 2 to 4 ounce serving. On a weight percentbasis of the product, the allergenic protein may be present at thelevels disclosed herein. For instance, the allergenic protein mayaccount for about 1.7 to about 3.5 wt % of the product. In anotherexample, where multiple allergenic proteins are present, each allergenicprotein may account for about 1.7 to about 3.5 wt % of the product, orthe total allergenic protein present may account for about 1.7 to about3.5 wt % of the product.

Methods of Production

The product may be produced by admixing one or more of: allergenicprotein(s), a prebiotic and/or a probiotic, another foodstuff, and otherproduct components. When in the admixture, the allergenic protein may beraw, processed, or combinations thereof. The admixed product may bepackaged. The packaged product may be treated. For instance, thepackaged product may be subjected to heat treatment to sanitize theproduct or otherwise kill harmful bacteria or a hot fill method may beused. Additionally, the components could be mixed, heat treated, hotfilled into the package, and rapidly cooled. For example, the packagedproduct may be heated to about 190 to about 203° F. in a heat exchangerfor 15-30 seconds then cooled to about 180° F. In addition oralternatively, the product may be sterilized by other means. Thesemi-solid components may be heat treated separately from the powderedcomponents and packaged for the consumer to mix prior to consumption.

Methods of Use

Approaches for delivering the allergenic protein may involve feeding thechild a predefined amount within the baby food product. The predefinedamount may be delivered on a periodic basis, which may be daily, onceevery two days, three times per week, or combinations. For instance, thechild may be fed about 6 grams of the allergenic protein on a weeklybasis, meaning the baby may ingest 2 grams of the allergenic protein ina feeding three days within a seven day period. Alternatively, the childmay be fed about 1 gram of the allergenic protein once a day. Asprovided herein, the predefined amount of the allergenic protein may beprovided in the packaged product. For instance, the predefined amountmay be provided in a serving of the product, such as a 1 ounce, 2 ounce,3 ounce, 4 ounce, 5 ounce or 6 ounce serving.

In some approaches, the allergenic protein is given to the childregularly beginning at about 3, 4, 5 or 6 months of age, or from about3-6 months of age, and may continue over an extended period such as 2months to 57 months, or up to age 1, 2, 3, 4 or 5.

Over this extended period, the amount of allergenic protein to which thebaby is periodically exposed remains constant. For instance, the childmay be fed 2 grams of the allergenic protein in a 2 ounce serving andmay ingest about 6 grams of the allergenic protein per week over anextended period. In some implementations, the serving size may increase,while the level of allergenic protein remains constant. For instance,during a first period, the child may be fed 2 grams of the allergenicprotein in a 2 ounce serving of the product and ingest about 6 grams ofthe allergenic protein per week, and then during a second period, may befed the 2 grams of allergenic protein in a 4 ounce serving of theproduct and continue to ingest the about 6 grams of the allergenicprotein per week.

By repeatedly exposing the child's immune system to these isolatesbeginning at an early age, such as at beginning at about 3, 4, 5, or 6months, immune tolerance to the allergenic food protein may be achieved.In some approaches, the isolates may be delivered once the child isready for solid foods, typically within the 4-6 month range. When theprebiotic and/or probiotic is present in the product, these componentsmay be simultaneously administered with the allergenic food protein.Prebiotics and/or probiotics can alter that infant microbiome and maydecrease the risk of food allergy development. The microbiome of thegastrointestinal tract has been shown to modulate immune response toingested allergens. Ingestion of pre/probiotics, which can alter theintentional flora has been proposed as a prevention strategy for allergy(Zuccotti G. et al. Probiotics for prevention of atopic diseases ininfants: systematic review and meta-analysis. Allergy. 2015; 70:1356-71;Fiocchi A., Pawankar R., Cuello-Garcia C., et al. World AllergyOrganization-McMaster University Guidelines for Allergic DiseasePrevention (GLAD-P): Probiotics. The World Allergy Organization Journal.2015; 8:4.). While not desiring to be bound by a particular theory, itis believed that consumption of a product with allergenic protein inaddition to a pre/probiotic in accordance with disclosed embodiments mayhave a synergistic effect in the induction of allergen tolerance innon-food allergic children.

The product would not be recommended for consumption in food allergicindividuals for treatment of food allergy. According to someimplementations, the child ingesting the product would be one that haspreviously tolerated a peanut protein-containing product or have arecommendation from a medical provider to introduce peanut into thediet. In addition or alternatively, the initial administration of theallergenic protein may be in the presence of a doctor.

As used herein, the term “about” modifying, for example, the quantity ofa component in a composition, concentration, and ranges thereof,employed in describing the embodiments of the disclosure, refers tovariation in the numerical quantity that can occur, for example, throughtypical measuring and handling procedures used for making compounds,compositions, concentrates or use formulations; through inadvertenterror in these procedures; through differences in the manufacture,source, or purity of starting materials or ingredients used to carry outthe methods, and like proximate considerations. The term “about” alsoencompasses amounts that differ due to aging of a formulation with aparticular initial concentration or mixture, and amounts that differ dueto mixing or processing a formulation with a particular initialconcentration or mixture. Where modified by the term “about” the claimsappended hereto include equivalents to these quantities.

Similarly, it should be appreciated that in the foregoing description ofexample embodiments, various features are sometimes grouped together ina single embodiment for the purpose of streamlining the disclosure andaiding in the understanding of one or more of the various aspects. Thesemethods of disclosure, however, are not to be interpreted as reflectingan intention that the claims require more features than are expresslyrecited in each claim. Rather, as the following claims reflect,inventive aspects lie in less than all features of a single foregoingdisclosed embodiment, and each embodiment described herein may containmore than one inventive feature.

Although the present disclosure provides references to preferredembodiments, persons skilled in the art will recognize that changes maybe made in form and detail without departing from the spirit and scopeof the invention.

What is claimed is:
 1. A baby food product, comprising: an admixture of:an allergenic protein; a predefined serving of a solid or semi-solidfoodstuff; and a probiotic, wherein the probiotic comprises one or moreof: lactobacilli, saccharomyces, bifidobacteria strains, bacilluscoagulans, or a combination, wherein the product is pre-packaged in asealed package, and wherein the packaged product is sanitized.
 2. Theproduct of claim 1, wherein the allergenic protein is selected from oneor more of: peanuts, a tree nut or eggs.
 3. The product of claim 1,wherein the allergenic protein is a non-animal based protein.
 4. Theproduct of claim 1, wherein the allergenic protein is one or more of:defatted, heat treated, or non-heat treated.
 5. The product of claim 4,wherein the allergenic protein is heat treated and an allergenicity ofthe allergenic protein is altered by the heat treatment.
 6. The productof claim 5, wherein the allergenicity of the allergenic protein isincreased.
 7. The product of claim 5, wherein the allergenicity of theallergenic protein is decreased.
 8. The product of claim 1, wherein thefoodstuff comprises one or more of a solid consumable food product or asemi-solid consumable food product.
 9. The product of claim 8, whereinthe solid consumable food product or the semi-solid consumable foodproduct comprises one or more of: a vegetable or fruit puree, a grainmeal or mash or a cereal.
 10. The product of claim 1, wherein theallergenic protein accounts for up to 3.5 wt % of the baby food product.11. The product of claim 1, wherein the baby food product furthercomprises a prebiotic.
 12. The product of claim 1, having up to about 25wt % fat content.
 13. The product of claim 1, wherein the packagedproduct contains a pre-defined amount of allergenic protein per serving.14. The product of claim 13, wherein the pre-defined amount ofallergenic protein is about 0.5 grams to about 2 grams.
 15. The productof claim 13, wherein the serving is a three to four ounce serving. 16.The product of claim 1, further comprising one or more of naturalpreservatives, viscosifiers, stabilizers, thickeners, emulsifiers,suspension agents, micronutrients, macronutrients, vitamins andminerals.
 17. A method of feeding a baby food product to a child,comprising: providing the child with a serving of the baby food productsuch that the child ingests a pre-defined amount of an allergenicprotein, the serving provided on a periodic basis such that the childingests about 6 grams of the allergenic protein per week over anextended period of weeks, wherein the baby food product comprises theallergenic protein and a probiotic, wherein the probiotic comprises oneor more of: lactobacilli, saccharomyces, bifidobacteria strains,bacillus coagulans, or a combination, wherein the product ispre-packaged in a sealed package, and wherein the packaged product issanitized.
 18. The method of claim 17, wherein the periodic basis is oneor more of daily, once every two days, once every three days orcombinations.
 19. The method of claim 17, wherein the amount ofallergenic protein ingested over the extended period remains constant.20. The method of claim 17, wherein the allergenic protein is selectedfrom one or more of: peanuts, a tree nut or eggs.